A randomised clinical study to compare time to post-operative recovery using propofol with either ketamine or dexmedetomidine by target control infusion in patients undergoing laparoscopic cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of mean/ median time taken to achieve Modified Aldrete score of ≥9.
研究概览
简要总结
Total intravenous anesthesia (TIVA) is a technique of general anesthesia which uses a combination of agents given via syringe pump exclusively by the intravenous route without the use of inhalation agents, which can be delivered reliably using target controlled infusion (TCI).
TCI is a more advanced method of IV drug infusion, which requires setting target plasma or target effect-site concentrations using a special infusion pump. Data on the pharmacokinetic parameters of the drug are programmed in the pump and the pump software.
Opioids are very commonly used in modern methods of anaesthesia. The use of opioids is based on their ability to provide analgesia during the peri operative period. Opioids used as the part of a balanced anaesthesia are known to have a lot of side effects such as sedation, respiratory depression, post-operative nausea and vomiting, urinary retention, constipation and opioid induced hyperalgesia. Analgesic effects, however, can be gained from different drugs while minimizing side effects particularly those of opioids, with added advantages of decreased postoperative nausea and vomiting and analgesic requirement post operatively.
Ketamine is a phencyclidine derivative. It provides excellent amnesia and analgesia, preserves muscle tone with maintaining airway reflexes and spontaneous respiration. It is postulated that combining propofol–ketamine may preserve sedative and analgesic efficacy while minimizing their respective adverse effects, It has a perioperative sedative, analgesic and anxiolytic properties similar to benzodiazepines but being α2 adrenoceptor agonist it has less side effects.
Justification:
TIVA: use of intravenous agents to provide anaesthesia
TCI: targeted infusion of drugs
Propofol, opioids, dexmedetomidine and ketamine: safely delivered by TCI
Combinations of propofol with opioids have been studied with respect to TIVA, but there are limited studies to compare propofol with either dexmedetomidine or ketamine by target control infusion regarding post-operative recovery in patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group of 18-65 yrs.
- •ASA I and ASA II.
- •Patients undergoing laparoscopic cholecystectomy.
排除标准
- 未提供
结局指标
主要结局
Comparison of mean/ median time taken to achieve Modified Aldrete score of ≥9.
时间窗: At the end of anaesthesia
次要结局
- • Mean/ median propofol consumed during surgery.(• Proportion of patients with haemodynamic complications such as hypotension, hypertension, bradycardia, tachycardia.)
研究者
Munira Sidhpurwala
Lady hardinge medical college